Pediatric OTCs Carolyn Whiskin, BScPhm. Disclosure Honoraria have been received from the following companies in preparing, reviewing and giving presentations:

Pediatric OTCsCarolyn Whiskin, BScPhm

Disclosure

Honoraria have been received from the following companies in preparing, reviewing and giving presentations:

Pfizer

Abbott

Merck

GlaxoSmithKline

Objectives

• To understand the Canadian Paediatric Society Guidelines regarding cough, cold and fever

• To understand treatment options and supportive measures for these conditions

• To be able to integrate homeopathic and traditional medication in pediatrics

The Common Cold

• Young children have lowered immunity to the more than 100 different cold viruses

• Not uncommon to get as many as 8–10 colds/yr before age 2

• Fewer colds with age as exposure increases and immunity develops

• Typical symptoms: runny/stuffed-up nose, sneezing, coughing ,headache, mild sore throat, loss of appetite, fatigue, mild fever

http://www.caringforkids.cps.ca/handouts/colds_in_children

When To Refer

Babies younger than 3 months

• having trouble breathing

• not eating, or if they are vomiting

• have a fever (rectal temperature of 38.5°C or higher)

When to ReferChildren of all ages

• Breathing rapidly or seem to be working hard to breathe

• Blue lips

• Coughing causing choking or vomiting

• Waking with one or both eyes stuck shut with dried yellow pushttp://www.caringforkids.cps.ca/handouts/colds_in_children

When to Refer

• Much more sleepy than usual, doesn’t want to feed or play, or is very fussy and cannot be comforted

• Thick or coloured (yellow, green) discharge from the nose for more than 10 to 14 days.

• Any sign of a middle ear infection (ear pain, drainage from the ear)

http://www.caringforkids.cps.ca/handouts/colds_in_children

Spreading a Cold

Viruses live in the nose, mouth, eyes and skin and can stay on surfaces for many hours

Germs can spread whenever we touch one of these things and then touch our nose, mouth or eyes before washing our hands

http://www.nj.gov/health/flu/documents/module3.pdf

Hand Washing

Hand washing

• 15 to 20 seconds with warm water and soap for the time it takes to sing “Happy Birthday” twice

• Avoid kissing, touching or holding hands

• Elbow cover cough – droplets spread several feethttp://www.caringforkids.cps.ca/handouts/

colds_in_children

Pertussis Prevention

• Also known as whooping cough

• 25 infant deaths in the USA in 2010 – majority spread from adults

• Adults age 19–65 require a Tdap booster

• Adults over 65 require a booster if they will be in close contact with an infant

• Pregnant woman not already vaccinated should receive a booster in the late 2nd semester or 3rd trimester

http://www.adultvaccination.org/whooping_cough_vaccine_pertussis_vaccination_adult_immunization.htm

Cough and Cold

• Health Canada Guidelines• As of the fall of 2009 all products containing

traditional antihistamines, antitussives, expectorants and decongestants are to be labelled “Not for use under age 6”

• Why the restriction?• Lack of evidence for these products in this age group• Reports of misuse, overdose and adverse effects

which include the following: increased heart rate, convulsions, decreased level of consciousness, abnormal heart rhythms and hallucinations

Why Restrictions?

• Body weight: children aged 2-6 can weigh the same as children under age 2 in whom these medications have not been indicated

• Increased exposure due to higher incidence of coughs and colds in this age group

• Children less likely to communicate adverse effects from these medications to caregivers

Standard Treatment Measures

Health Canada feels that most colds resolve in 6-10 days and that there is no “cure” for the common cold

Pharmacists can feel comfortable suggesting the following:

• Clear nasal passages and ensure that the child gets enough rest

• Ensure the child gets plenty of clear fluids (e.g., diluted non-sweetened fruit juice, or clear soups)—this prevents dehydration, reduces congestion and keeps the throat moist

• Provide a comfortable environment with enough humidity

Which Humidifier To Use?

• Safety-Cool mist preferred to avoid burns

• Effectiveness Warm-mist and cool-mist humidifiers are equally effective. When water vapor reaches the lower airways, the temperature is the same. Aim away from bed and sheets.

• Cost Cool-mist humidifiers are less expensive than are warm-mist

• Cleaning clean to prevent the growth of bacteria and molds. Wiping down the humidifier daily with a 10 percent bleach solution — 9 parts water to 1 part bleach — is one way to safely keep it clean

http://www.mayoclinic.com/health/cool-mist-humidifiers/AN01577

Humidifiers add moisture to the air, which helps ease coughing and congestion due to a cold

Clearing Nasal Passages

• Suction with rubber bulb

• Squeeze the bulb syringe to expel air

• Insert the tip of the bulb about 1/4 to 1/2 inch (0.64 to 1.27 centimeters) into baby's nostril, pointing toward the back and side of the nose

• Release the bulb, holding it in place while it suctions the mucus

• Remove the syringe and empty the contents onto a tissue by squeezing the bulb rapidly while holding the tip down.

• Clean the bulb syringe with soap and water

http://www.mayoclinic.com/health/common-cold-in-babies/DS01106/DSECTION=lifestyle-and-home-remedies

Nasal Aspiration

• First may use saline solution to dilute secretions

• Wash device with warm water

• Insert filter

• Insert bulb into nostril while placing mouthpiece in caregiver’s mouth for inhalation

• Remove filter and clean device

Saline Solutions

Benefits of rinsing: flushes out thickened mucus and irritants, may help ease swelling in the lining of nasal passages

Irrigation solution preparation: dissolve 1/8 teaspoon of table salt into 8 ounces of warm water

Commercially available products use sodium chloride 0.9%; sea salt based products use a deiozinizing process to bring to isotonic while leaving natural minerals

Homeopathy: View of the CPS

• Canadian Paediatric Society reviewed PubMed, CAM on PubMed, the Cochrane Library and Health Canada’s websites.

• No trials analyzing the effects of over-the-counter pediatric homeopathic preparations were found.

• There are only a few good studies showing possible benefits of homeopathy when prescribed by trained practitioners for a selected number of specific conditions in children.

• Therefore, more rigorous studies showing efficacy need to be completed before it can be recommended as a credible complementary or alternative therapy for the pediatric population.

Homeopathy: View of the College of Family Physicians of Canada

• “It is important to keep in mind that, when used appropriately, natural health products can be a key part of a person’s health management.”

• “Consumers can identify a Health Canada authorized natural health product by the eight-digit Natural Product Number (NPN) or Drug Identification Number for Homeopathic Medicine (DIN-4HM) on the label. These products are also required to have clear labeling on appropriate use, including dosing, risk information and whether they can be used safely in children.”

http://www.cfpc.ca/cough and cold medications frequently asked questions

More Comments

• 1997, by K. Linde et al. (Munich University) published meta-analysis of 135 clinical trials which compared homeopathic drugs with a placebo concluded that

"the results of this meta-analysis are not compatible with the hypothesis that the clinical effects of homeopathy are completely due to placebo."

1997, by K. Linde et al. (Munich University

Natural Health Product Options

Coryzalia• Approved from one month – 6 years

of age

• Indications: nasal congestion, runny nose and sneezing

• Dose: unit dose liquid vial t.i.d. for 5 days

Euphorbium• Open, multicenter, prospective, active-

controlled cohort study in patients with inflammatory processes and diseases of the upper respiratory tract.The primary outcome was to demonstrate non-inferiority of the homeopathic complex remedy to xylometazoline.

• Results: comparable efficacy and tolerability profile of Euphorbium compositum nasal drops SN and xylometazoline in patients with inflammatory processes and diseases of the upper respiratory tract (rhinitis/sinusitis).http://www.ncbi.nlm.nih.gov/pubmed/

15772459

Euphorbium

• In vitro study using virus plaque reduction assays examined the effect of Euphorbium compositum SN against pathogens causing various viral infections: influenza A virus, respiratory syncytial virus (RSV), human rhinovirus (HRV) and herpes simplex virus type 1 (HSV-1).

• Euphorbium showed antiviral activity of against RSV and HSV-1. In addition, an antiviral effect against influenza A virus and HRV.

http://www.ncbi.nlm.nih.gov/pubmed/11574744

Euphorbium

Dose

• Nasal Spray: Age 2 to 12 years,1 spray into each nostril 3 times a day

• Oral Drops: Age 2-6, 5 drops 3x/day Age 6-12, 7 drops 3x/day

• Acute Dosage: May use drops every 30-60 minutes up to 12x/d

Natural Health Products

Viburcol• Indicated for infants and

children for: teething, pain, colic, infections with or without fever, sleeplessness and restlessness

• Dose: Age 0-2, 5 drops 3 x/day Age 2-6, 8 drops Age 6-12, 10 drops Acute – every 30-60 minutes

Suppository: 1 b.i.d. – 0-12 yrs Acute use every 1-2 hours

Viburcol

Nonrandomized observational study of 38 Belgian centers practising homeopathy

and conventional medicine

Children <12 years old comparable to acetaminophen for poor eating, cramps, distress, sleep, crying and temperature

Cough

• An RCT with 139 children (24 to 60 mo) suffering from cough due to upper respiratory tract infection reported that 2.5 mL of honey before sleep improved cough frequency and severity, as well as sleep quality in a mean of 59% of children

• Honey was significantly superior to no treatment or honey-flavoured DMcough frequency and severity, bothersome nature of the cough, and the child/parent sleep quality, as rated by the parents

http://www.cps.ca/en/documents/position/treating-cough-cold

Honey in Infants Younger Than 1 Year

• Only food linked to infant botulism

• Infant botulism is caused by bacteria called Clostridium botulinum

• If honey is contaminated:

spores toxins paralysis

• Bacteria and toxins are odourless, colourless, tasteless and not destroyed by cooking

Health Canada is advising parents and caregivers not to feed honey to children younger than 1 year of age

• http://www.hc-sc.gc.ca/fn-an/securit/kitchen-cuisine/infant-botul-infantile-eng.phphttp://www.hc-sc.gc.ca/fn-an/securit/kitchen-cuisine/infant-botul-infantile-eng.php

Fever

Normal temperature ranges

Method Normal temperature range

• Rectal 36.6°C to 38°C (97.9°F to 100.4°F)

• Ear 35.8°C to 38°C (96.4°F to 100.4°F)

• Oral 35.5°C to 37.5°C (95.9°F to 99.5°F)

• Axillary 34.7°C to 37.3°C (94.5°F to 99.1°F)

http://www.cps.ca/en/documents/position/temperature-measurement

Measurement Methods

Summary of recommended temperature measurement techniques

Age Recommended technique

• Birth to 2 years 1. Rectal (definitive) 2. Axillary (screening low risk children)

• 2 to 5 years 1. Rectal (definitive) 2. Axillary, Tympanic (or Temporal Artery if

in hospital) (screening)

• Older than 5 years 1. Oral (definitive) 2. Axillary, Tympanic (or Temporal Artery if in

hospital) (screening)

• Canadian Task Force on Preventive Health - Strength of Recommendation B, II [39]


Oral

• Measures temperature of lingual arteries

• Influenced by food/drink and oral breathing

• Relies of mouth sealed and tongue depressed for 3-4 minutes

• Mercury thermometers are no longer recommended


Rectal

• Gold standard measurement

• Slower to change based on core temperature changes

• Affected by insertion depth and stool presence

• Rectal perforation rare occurance- caution in neonates (1 in 2 million measurements)

• Cleaning needed to prevent spread of fecal contaminants


Axillary

• Inaccurate estimate of core temperature in children

• Exact placement over axillary artery required

• Environmental influences

• Suggested as a screening in neonates by the American Pediatric Society

Tympanic

• Measures thermal radiation emitted from the tympanic membrane

• Crying, otitis media and wax do not affect readings

• Ideal location for core temp. determination

• Instrument design, depth of insertion and shape of ear canal can all cause variations

• Size of device may affect accuracy in children under 2 years

When to Treat

• Fever is a sign that the body is working to fight infection – should not be feared

• Fever has a purpose and may resolve viral infections sooner

• Treatment mainly to provide comfort and reduce parent anxiety

• Do not wake a sleeping child to give them a fever reducer

• Hydration and watching behavioural change emphasized

• No evidence fever reduction reduces morbidity and mortality or decreases the recurrance of febrile seizures

When To Refer

• Child with fever is less than 6 months old

• Fever for longer than than 72 hours

• Child is excessively cranky, fussy or irritable

• Child is excessively sleepy, lethargic or does not respond

• Child is persistently wheezing or coughing

• Fever accompanies rash or any other signs of illness that are concerning

http://children.webmd.com/news/20110228/new-advice-fighting-fever-children

Treatment Choices

Acetaminophen

• Dose: 10-15 mg/kg per dose q4-6h

• No proof that a loading dose of 30 mg/kg works better

• Onset of Action: 30-60 minutes

• Risk of hepatotoxity with doses over 15mg/kg or at intervals less than 4 hours

• Combination treatment may offer slight benefit

http://pediatrics.aappublications.org/content/127/3/580/T1.expansion.html

Treatment Choice

Ibuprofen• Dose: 10mg/kg/ dose every 6-8 hours

• Does not worsen asthma symptoms

• Can cause gastritis, bleeding and ulcers- less common in acute illness

• Nephrotoxicity – renal insufficiency can develop; concern in dehydration where prostaglandin synthesis needed for renal blood flow.- caution in cardiac and renal patients

• Not to be used in infants younger than 6 monthshttp://pediatrics.aappublications.org/content/127/3/580/T1.expansion.html

American Academy of Pediatrics

Variable Acetaminophen Ibuprofen

• Decline in temperature, °C 1–2 1–2

• Time to onset, h <1 <1

• Time to peak effect, h 3–4 3–4

• Duration of effect, h 4–6 6–8

• Dose, mg/kg 10–15 every 4 h 10 every 6 h

• Maximum daily dose, mg/kg 90 mg/kg 40 mg/kg

• Maximum daily adult dose, g/d 4 2.4

• Lower age limit, mo 3 6http://pediatrics.aappublications.org/content/127/3/580/T1.expansion.html

Combination Treatment

• Studies indicate combination therapy may be more effective in reducing fever

• May not improve discomfort

• Caution safety of combination treatment

• Dosage confusion can lead to overdose

• Generally not recommended

http://pediatrics.aappublications.org/content/127/3/580/T1.expansion.html

Fighting the Virus

Oscillococcinum

• RCT showed benefit over placebo in complete resolution or clear improvement in 48 hours (48% vs 63%)

• Give one unit dose tube of pellets every 6 hours for 3 doses at the onset of symptoms. Ages 2 y and up (separate from food/toothpaste)

Papp R, Schuback G, Beck E, et al. Oscillococcinum in patients with influenza-like syndromes: a placebo-controlled, double-blind evaluation. Br Homeopath J 1998;87:69-76

Fighting the VirusSambucol

• In an RCT – reduced flu symptoms to 3-4 days; influenza antibodies increased and TNF-alpha production increased (44.9 fold)

• Study concluded that, in addition to its antiviral properties, Sambucol Elderberry Extract and its formulations activate the healthy immune systemhttp://www.ncbi.nlm.nih.gov/pubmed/11399518;

The effect of Sambucol, a black elderberry-based, natural product, on the production of human cytokines: I. Inflammatory cytokines

http://www.ncbi.nlm.nih.gov/pubmed/11399518

Sambucol

Daily maintenance

Children 1-6 years of age: take 1 teaspoon (5 mL) daily

Children 7-12 years of age: take 2 teaspoons (10 mL) daily

Intensive use

Children 1-6 years of age: take 1-2 teaspoons (5-10 mL) twice daily

Children 7-12 years of age: take 2-3 teaspoons (10-15 mL) twice daily

Fighting the VirusEngystol

• RCT and observational studies show comparable results to acetaminophen in reducing symptoms and phagocytic activity improved

• Children (6 to 12 years) 1 tablet 2 times daily. In acute cases, 1 tablet every 1 to 2 hours, up to 8 times a day

• Young children (2 to 6 years) ½ tablet 3 times daily. In acute cases, 1 tablet every 1 to 2 hours, up to 6 times a day

• Babies (0 to 2 years) ½ tablet 2 times daily. In acute cases, 1 tablet every 1 to 2 hours, up to 4 times a day

• Dissolve slowly in the mouth or in a teaspoon of water before administering to a young child or baby

http://www.homotoxicology.net/Documents/Brochures/Engystol.pdf

Other Options

Echinacea

• 2006 Cochrane review identified 16 controlled trials on the effect of echinacea for cough—no sufficient data to suggest the effectiveness of echinacea in children. The use of echinacea for eight to 12 weeks as a prophylactic measure did not result in effective prevention of the common cold (Source: CPS)


Other Options

Zinc

• Some studies showed benefits, especially if used within 24 h of the onset of common cold symptoms

• Other studies showed no benefit

• At the present time, the use of zinc in children with cough and cold is not recommended (Source: CPS)


Vaccinations

• Use of anti-pyretics before vaccination may reduce the immune response

• Sugar water preferred to reduce discomfort before vaccination• To make sugar water, mix one

packet of sugar (1 teaspoon) with 10 ml of water (2 teaspoons). Administer with a cup, spoon or syringe just before the needle and discard the unused portion

http://www.toronto.ca/health/immunization_children/pdf/howtoreducepain.pdf

Making a DifferenceProviding information to parents

regarding the care of their sick child is a vital service

pharmacists provide to the community

Take the time to share your knowledge

We all benefit!!